combined with antiretroviral therapy, the control group will take placebo 2 tabs tid per day lasting for 6 months and then switch to take Triplitode 2 tabs tid po for anther 6 months

Drug: Triptolide

Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular.

Other Name: Tripterygium Wilfordii Hook F (TwHF)

Drug: cART

Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.

Other Name: Antiretroviral therapy

Drug: placebo

Placebo pills produced the same as Triptolide wilfordii.

Other Name: sugar pills

Experimental: Triptolide + cART

combined antiretroviral therapy, the experimental group will take Triptolide 2 tabs tid po per day for 12 months.

Drug: Triptolide

Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular.

Other Name: Tripterygium Wilfordii Hook F (TwHF)

Drug: cART

Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.

Other Name: Antiretroviral therapy

Detailed Description:

About 120 patients will be recruited from 4 HIV/AIDS clinical centers in China and randomized 1:1 into intervention group and placebo-controlled group. Triptolide wilfordii (20mg tid po) would be given to invention group for 24 weeks. T cell activation and inflammation biomarkers including CD8+HLA-DR+CD38+, IL-6, D-Dimer and high-sensitivity C-reactive protein (hsCRP), protein degradation-1 (PD-1), Ki67 ,soluble CD14 and CD163, PD-1, CCR5 and CD57 would be tested. Patients in placebo-controlled group will change to take Triptolide wilfordii (20mg tid po) for another 24 weeks. All patients will be followed up till 48 weeks. We hypothesis that Triptolide wilfordii might reduce immune activation and inflammation of HIV immunological non-responders and increase CD4 T cell count, which provides a new strategy for treatment of HIV-infected immunological non-responders.

Those who are undertaking steroids, immunomodulator, anti-inflammatory agents

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01817283